Accountability Procedures. Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the study, unmasked designated study staff must provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the Investigator or delegate must maintain records of IP dispensation and collection for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. All IPs sent to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • All unused products are available for return to the Study Sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event AE (ie, ADE or SADE) are returned to the Study Sponsor for investigation, unless otherwise directed by the Sponsor. Refer to Section 11 of this protocol for additional information on the reporting of device deficiencies and AEs and the return of study products associated with these events. The Investigator is responsible for proper disposition of all unused IPs at the conclusion of the study, according to the instructions provided in the MOP.
Accountability Procedures. Upon receipt of the IPs, the investigator or delegate must conduct an inventory. Throughout the study, the investigator or delegate must maintain records of IP dispensation and collection for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. All IPs sent to the investigator must be accounted for by study sponsor personnel, and in no case be used in an unauthorized situation. The investigator should make every effort to collect unused lenses, foils, and supplies from subjects. It is the investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All unused products are available for return to the study sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event (i.e., ADE or SADE) are returned to the study sponsor for investigation, unless otherwise directed by the sponsor. Refer to Section 11 of this protocol for additional information on the reporting of device deficiencies and AEs and the return of study products associated with these events. The investigator is responsible for proper disposition of all unused IPs at the conclusion of the study, according to the instructions provided in the MOP.
Accountability Procedures. It is the investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All unused products are available for return to the study sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event (i.e., ADE or SADE) are returned to the study sponsor for investigation, unless otherwise directed by the sponsor. Refer to Section 11 of this protocol for additional information on the reporting of device deficiencies and AEs and the return of study products associated with these events.
Accountability Procedures. Dissemi- nation of various levels of classified in- formation or material shall be within the control and responsibility of des- ignated control officers. Particularly stringent controls shall be placed on information and material classified as TOP SECRET.
Accountability Procedures. Upon receipt of the study lenses, the Investigator or delegate will conduct an inventory. Designated study staff will provide the study lenses to the subjects in accordance with their randomization schedule. Throughout the study, the Investigator or delegate must maintain records of study treatment dispensation and collection for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of clinical supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • All unused products are available for return to the Study Sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event [ie, ADE or SADE] are returned to the Study Sponsor for investigation. Refer to Section 7.3 of this protocol for additional information on the reporting of device deficiencies and AEs and the return of study products associated with these events.
Accountability Procedures. Upon receipt of the IPs, the investigator or delegate must conduct an inventory. During the study, it is recommended that the investigator delegates staff to provide the IPs to the subjects in accordance with their randomization assignment. All members associated with the study at the site should make an attempt to remain masked, except for designated staff who will be dispensing IP and completing IP dispensation and collection records. These records must be made available to the study monitor for the purposes of verifying the accounting of IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. All IPs sent to the investigator must be accounted for by study sponsor personnel, and in no case be used in an unauthorized situation. It is the investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All unused products are available for return to the study sponsor, as directed • All used lidding foils are available for return to the study sponsor, as directed Unscheduled Visits and Early Termination Visits are allowed, if necessary. Study lenses will be provided to the subjects to take home for daily wear during the course of the trial. Study randomization will occur at Visit 1 with assigned lenses provided to take home at Visit 1 and Visit 2. Study contact lens fitting will occur at Visit 1 for both study lenses. If a subject cannot be successfully fit (either study lens) according to the study lens fitting guides as determined by the investigator, they will be required to exit from the study. Lubrication/rewetting drops will not be permitted during this study.
Accountability Procedures. Designated study staff will provide the study lenses to the subjects in accordance with their randomization schedule. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner
Accountability Procedures. Designated unmasked site personnel will dispense the study contact lens solutions (re-labeled OFPM and the site/subject purchased commercially labeled HMPS) in accordance with their assigned subject ID number and the randomization treatment order allocated to them. The identity of the test product will not be revealed to the subject and the order of use of the test and control products will not be revealed to the Investigator. It will not be possible to maintain full subject masking due to the nature of the cleansing devices, but the brand name will be masked for the test solution. During the study, the investigational site must maintain records of study treatment dispensation and collection by the unmasked personnel for each subject. This record must be made available to the designated study monitors for the purposes of verifying the accounting of clinical supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with a detailed explanation. Study contact lens cleaning devices associated with a device deficiency or with any product-related AEs must be returned to the Sponsor or manufacturer (for comparator/reference product). Refer to Section 12 for additional information on the reporting of device deficiencies or product-related AEs. At the conclusion of the study, the Investigator will be responsible for returning all used and unused study supplies unless otherwise instructed by the Sponsor. Upon receipt of the test products (OFPM test solution kits) from Alcon, the unmasked coordinator will conduct an inventory. During the study, the unmasked coordinator must maintain records of study treatment dispensation and collection for each subject including study solutions (test OFPM or purchased control HMPS). This record must be made available to the study monitor for the purposes of verifying the accounting of clinical supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. At the conclusion of the study, the Investigator will be responsible for returning all used and unused study supplies unless otherwise instructed by the Sponsor.
Accountability Procedures. The Investigator will procure both investigational products (test and control lenses). Details related to the procurement, labeling, handling, dispensing and final disposition are outlined below. The product must be tracked/accounted for through all steps of the procedure.
Accountability Procedures. Upon receipt of IPs, the Investigator or delegate must conduct an inventory of the test product by serial number, complete study-specific confirmation of receipt procedures as described in the management manual of test product , and retain any required documentation in the Investigator’s clinical study records. Throughout the study, the Investigator or delegate must maintain records of IP dispensation for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. All IPs sent to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized manner. • Return to the Study Sponsor investigational products associated with a device deficiency. Refer to Section 11 of this protocol for additional information on the reporting of device deficiencies and to the management manual of test product for information on return of study products associated with these events. The Investigator is responsible for proper disposition of all unused IPs at the conclusion of the study, according to the instructions provided in the management manual of test product.
